Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury

Summary

Neuropathic pain is a common complication following spinal cord injury (SCI) that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications. Nabilone and an anti-inflammatory diet are two treatments that may provide pain relief while being better tolerated. This study will evaluate the benefits of these treatments for neuropathic pain after SCI. Study participants will receive either an anti-inflammatory diet or a placebo diet, and nabilone or a placebo for 4 weeks. It is expected that an anti-inflammatory diet and nabilone will significantly decrease pain intensity and improve function. The combination of both treatments together is expected to have a greater effect than each alone.

Conditions

• Spinal Cord Injuries
• Neuropathic Pain

Interventions

OTHER

Placebo diet

The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional "cheat" foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week).

OTHER

Anti-inflammatory diet

Participants will also be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional "cheat" foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week)

DRUG

Nabilone Capsules

Capsules will be 0.5mg nabilone. Participants will undergo a 5-week titration period by taking 1 (0.5mg) nabilone capsule per day for a three-day period. The dose will be increased on a fixed schedule by 1 (0.5mg) capsule every three days to a maximum of 8 capsules/day (4mg). Dosage will be maintained if higher doses are not tolerated or if sufficient relief is obtained (at least a 2-point change on the NRS). Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 4-week treatment period.

OTHER

Placebo capsules

Placebo capsules contain no active ingredient. Participants on placebo capsules will undergo the same 5-week titration period and intervention period as those on active treatment.

Sponsors & Collaborators

• Ontario Neurotrauma Foundation

  collaborator OTHER

• Eldon Loh, MD

  lead OTHER

Principal Investigators

• Eldon Loh, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

• David Ditor, MD · Brock University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2024-05-01

Completion

2024-12-01

Countries

• Canada

Study Locations